BD Kiestra InoqulA+Recalls & reported problems across all models

We found 2 models of BD Kiestra InoqulA+ by BD Kiestra B.V. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2019 and Aug 24, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (13 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Kiestra InoqulA+ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 26, 2019Terminated

   An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

   Z-2438-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported BD Kiestra InoqulA+ problems

BD Kiestra InoqulA+ models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Kiestra™ InoqulA+™ 447202

  DEVICE, MICROTITER DILUTING/DISPENSING
  1 recall30 reports
• BD Kiestra™ InoqulA 446973

  DEVICE, MICROTITER DILUTING/DISPENSING
  4 reports

Recent BD Kiestra InoqulA+ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It has been reported that the BD Kiestra InoqulA has been found producing a false negative result. No patient impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409246 ↗
• MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING INCORRECT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT URINE SAMPLES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034193 ↗
• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS PATIENT RESULTS DURING USE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524748 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS PATIENT RESULTS DURING USE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471643 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING ERRONEOUS RESULTS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926873 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem

  IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING POTENTIAL INCORRECT RESULTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628035 ↗
• MalfunctionNov 15, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE BARCODA GAS SPRINGS ON THE BD KIESTRA INOQULA DID NOT HOLD THE HOOD UP. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693881 ↗
• MalfunctionNov 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD KIESTRA INOCULATION SYSTEM, THERE WAS POSSIBLE CONTAMINATION OF THE SLIDE PROCESSING MODULE WHICH LED TO A FALSE PATIENT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586987 ↗
• MalfunctionApr 9, 2024Structural Problem; Structural Problem

  IT WAS REPORTED WHEN USING THE BD KIESTRA INOQULA THE BARCODA PRINTER HOOD SPRING COULD NOT KEEP THE LID OPEN AND WOULD CLOSE ON ITS OWN. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069773 ↗
• MalfunctionFeb 16, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA DID NOT DISPENSE SAMPLE ON PLATES RESULTING IN NO GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722776 ↗
• MalfunctionFeb 5, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHEN USING THE BD KIESTRA INOQULA THERE WAS FALSE NEGATIVE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641224 ↗
• MalfunctionDec 6, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THERE WAS A FALSE NEGATIVE RESULT. NO PATIENT IMPACT OR CHANGE IN TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278464 ↗
• MalfunctionNov 3, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CULTURING HUMAN MILK FROM THE LACTARIUM WITH 250UL ON BLOOD AGAR AND 250UL ON CHAPMAN (SEARCH FOR S. AUREUS). ON THE BA, THERE IS NO S. AUREUS BUT THERE ARE LARGE QUANTITIES ON THE CHAPMAN. WE MANUALLY RE-INOCULATED THIS MILK AND WE DID NOT FIND ANY S. AUREUS CULTURE AT 24 HOURS EITHER ONBA OR ON CHAPMAN. CONCERNED DISH (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066912 ↗
• MalfunctionOct 24, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD KIESTRA INOQULA, THERE WAS A FALSE NEGATIVE OF ONE SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10 UL OF SAMPLE INOCULATED ON DRIG: (B)(4), SS: (B)(6) AND INOCULATION OF A BROTH WITH 150 UL OF SAMPLE. THE CULTURES ARE NEGATIVE ON DRIG AND SS BUT POSITIVE CULTURE AFTER ENRICHMENT. 48H AFTER FA THE CUSTOMER PROCESSED THE SAMPLE MANUALLY AND IT WENT POSITIVE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995089 ↗
• MalfunctionJul 7, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE BD KIESTRA INOQULA OBTAINED A FALSE NEGATIVE RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RANDOM NO GROWING IN SOME INOCULATED DISHES. CAN YOU KINDLY CONFIRM IF THERE IS PATIENT SAMPLES WERE INVOLVED? YES THERE WERE PATIENT SAMPLES INVOLVED. I. DID THE COURSE OF TREATMENT CHANGE? IF YES, PROVIDE DETAILS. THE COSTUMER IS NOT AWARE OF THIS HAPPENING. THEY IDENTIFIED THAT THE PDV MIGHT BE FAILING BECAUSE THEY SAW SOME SAMPLES WHERE THE ABUNDANCE OF BACTERIA IN GRAM STAINED SLIDES DID NOT MATCH THE ABSENCE OF GROWTH IN THE OTHER PLATES FOR THAT PATIENT. BECAUSE THEY HAVE THE GRAM STAIN AS A DOUBLECHECK, THEY MANUALLY INOCULATED THE SAMPLES AGAIN FOR A SECOND TIME IN THE SAME KIND OF PLATES AND THERE WAS GROWTH. THE ONLY CHANGE FOR THIS SAMPLES WOULD HAVE BEEN A DELAY IN REPORTING RESULTS BACK. MORE SAMPLES WITHOUT GRAM STAIN MIGHT HAVE BEEN AFFECTED BUT THE COSTUMER WAS NOT AWARE OF IT. II. WERE THERE ERRONEOUS RESULTS? IF YES, PROVIDE DETAILS. AGAIN THE COSTUMER REALIZED IN THE SAMPLES WITH THE GRAM, AND DOESN¿T KNOW IF ANY FALSE NEGATIVE MIGHT HAVE GONE OUTIN SAMPLES WITHOUT GRAM. AS FAR AS WE KNOW, THERE WERE NO ERRONEOUS RESULTS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278430 ↗